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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000006355
Receipt No. R000007537
Scientific Title Pemetrexed Monotherapy for Performance Status 2 Patients in Treatment of Relapsed Non-squamous and Non-small Cell Lung Cancer
Date of disclosure of the study information 2011/09/15
Last modified on 2014/12/11

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Basic information
Public title Pemetrexed Monotherapy for Performance Status 2 Patients in Treatment of Relapsed Non-squamous and Non-small Cell Lung Cancer
Acronym Pemetrexed monotherapy for PS2 patients with Non-sq NSCLC
Scientific Title Pemetrexed Monotherapy for Performance Status 2 Patients in Treatment of Relapsed Non-squamous and Non-small Cell Lung Cancer
Scientific Title:Acronym Pemetrexed monotherapy for PS2 patients with Non-sq NSCLC
Region
Japan

Condition
Condition non-squamous non-small cell lung cancer
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the efficacy and safety of pemetrexed monotherapy for performance status 2 pretreated patients with metastatic non-squamous non-small cell lung cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Overall survival
Key secondary outcomes Response rate
Progression-free survival
Disease control rate
Safety

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Pemetrexed at a dose of 500 mg/m2 every 3 weeks is administered until progression disease.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Histologically or cytologically proven non-squamous non-small cell lung cancer
(except large cell neuroendocrine carcinoma)
2)Non-squamous non-small cell cancer patients with stage IIIB(with pleural dissemination or malignant pleural effusion),stage IV or recurrent disease after surgery,who have 1 or 2 prior chemoterapy
3)With measurable or inmeasurable lesion
4)If the patient underwent radiotherapy, there should be the following interval between the radiotherapy and the registration
i)Radiotherapy including pulmonary field ->3 months
ii)Radiotherapy other than thoracic radiation ->1 weeks
5)over 20 years old
6)ECOG PS 2
7)History of 1 or 2 prior chemotherapy (EGFR-TKIs and UFT can be uncountable)
8)In patients with sensitive EGFR mutations, they become eligible after failure of EGFR-TKIs.
9)Adequate organ function
10)Life expectancy more than 3 months
11)Written informed consent
Key exclusion criteria 1)Interstitial pneumonia or pulmonary fibrosis detectable on CT scan
2)History of drug induced interstitial pneumonia
3)History of severe drug allergy
4)History of active infection or other serious disease condition
(GI bleeding,etc.)
5)History of poorly controlled pleural effusion,pericardial effusion and ascites
6)History of severe heart disease(uncontrollable arrythmia, uncontrollable angina pectoris, herat failure, etc.)
7)Uncontrollable diabetes mellitus
8)History of symptomatic brain metastases
9)Hystory of active double cancer
10)History of active psychological disease
11)Patients whose participation in the trial is judged to be inappropriate by the attending doctor
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuyuki Katakami
Organization Institute of Biomedical Research and Innovation
Division name Division of Integrated Oncology
Zip code
Address 2-2, Minatojima-minamimachi, Chuo-ku, Kobe
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Akito Hata
Organization Institute of Biomedical Research and Innovation
Division name Division of Integrated Oncology
Zip code
Address 2-2, Minatojima-minamimachi, Chuo-ku, Kobe
TEL
Homepage URL
Email a-hata@fbri.org

Sponsor
Institute Hanshin Cancer Study Group
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 神戸市立医療センター 中央市民病院
神戸大学医学部付属病院 呼吸器内科
先端医療センター 総合腫瘍科
兵庫県立がんセンター 呼吸器内科
大阪府立成人病センター 呼吸器内科
刀根山病院 呼吸器内科
倉敷中央病院 呼吸器内科
桂病院 呼吸器内科

Other administrative information
Date of disclosure of the study information
2011 Year 09 Month 15 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2011 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 08 Month 01 Day
Last follow-up date
2014 Year 07 Month 01 Day
Date of closure to data entry
2015 Year 07 Month 01 Day
Date trial data considered complete
2015 Year 07 Month 01 Day
Date analysis concluded
2015 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 09 Month 15 Day
Last modified on
2014 Year 12 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007537

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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